Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device source, brachytherapy, radionuclide
Regulation Description Radionuclide brachytherapy source.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKXK
Submission Type 510(k)
Regulation Number 892.5730
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources
Third Party Review Not Third Party Eligible
-
-